Surgical scaffold

ABSTRACT

A scaffold for reshaping an ear or a nose, the scaffold being configured to be i) attached to the cartilaginous portion of an ear or ii) attached to the cartilaginous portion of a nose, wherein the scaffold is formed at least in part from a shape-memory material and/or a plastic material and is capable of transforming from a first configuration to a second, pre-programmed configuration.

The present invention relates to a scaffold for reshaping an ear or noseof an animal, preferably a human, wherein the scaffold is formed atleast in part from a shape-memory material or a plastic material.

Prominent ear and nose deformity is common amongst the human population.

Firstly the problem of ear deformity will be considered. An ear whichprojects more than 17 mm from the side of the head is usually perceivedas prominent. By this estimate, up to 5% of the population may beaffected. Both ears are commonly affected, although occasionally justone side is prominent. The prominence may be the result of a poorlyformed or absent antihelical fold (FIGS. 1 and 2). Or it may be theresult of a deep conchal fossa (FIGS. 1 and 3). Alternatively, both ofthese abnormalities may need to be addressed when correcting prominentears.

There are a number of known methods for addressing the problem ofprominent ears. These methods may be divided into two categories, thoseinvolving otoplasy surgery (a procedure to change the shape of the ear)and those avoiding surgery. Examples of each of these categories willnow be briefly discussed.

A number of operations (otoplasty surgery) are available to correct eardeformities. These vary from very invasive procedures to reshape thecartilage to minimally invasive procedures. The principle involved inall of these procedures is reshaping of the cartilage which gives theear its prominence.

Standard, invasive, otoplasty surgery is a lengthy procedure which takesapproximately 90 minutes (45 minutes for one ear). A large number ofcomplications have been associated with this type of surgery. Theseinclude: problems with infection, bleeding, skin necrosis, death fromgeneral anaesthesia, recurrence of the prominence, keloid orhypertrophic scarring, asymmetry, palpable sharp edges (where thecartilage has been cut), pain, numbness and coldintolerance/sensitivity.

Minimally invasive otoplasty procedures (using needles or similarinstruments) to reshape the cartilage have fewer complications and takeless time (15 minutes for each ear), but are also less successful atachieving corrections of ear prominence. Asymmetry and palpable sharpedges are also more common compared with standard otoplasty surgery.

A further disadvantage of both standard otoplasty surgery and minimallyinvasive otoplasty procedures is that surgeons must undergo lengthy andcostly training to learn the relevant surgical techniques. Furthermore,the results of the first 10-20 cases are likely to be unpredictable.There is currently no means by which this can be avoided.

To avoid some of the problems associated with otoplasty surgery severaldevices have been developed to correct prominent ears, which avoidsurgery altogether.

An example of such a device is known as Earbuddies™. At birth and for avariable time afterwards (up to six months), the cartilage of the humanear remains soft and deformable. Therefore, external forces applied tothe cartilage can result in permanent changes to its shape. After sixmonths, the cartilage becomes more firm and more resistant todeformation. In the first few years of life, Earbuddies™ take advantageof the deformability of the cartilage. A piece of soft wire coated insilicone (for comfort) is moulded and placed onto the outside of the earand taped into position (FIGS. 4 a to 4 c). The cartilage moulds itsshape to that of the ear buddy and any prominence is corrected. Moreinformation on how the device is used is available from the website forthe device at http://www.earbuddies.co.uk/pws/index.htm. Earbuddies™ arevery successful when used in children up to the age of about 6 months.Thereafter, the cartilage becomes more firm and the length of time thatthe splint needs to remain in place to exert an effect makes itimpractical to use. This is compounded by the increasing dexterity ofthe child who will try (and usually succeed) in removing the splint,thereby reducing its effectiveness.

An alternative device, which avoids the need for surgery is known asAuri®Clip. The Auri®Clip applies gentle, continuous, external pressureto the cartilage of the ear in the region of the antihelical fold (FIGS.1, 5, 6). This deforms the cartilage in this area over a prolongedperiod of time to make the ears lie flatter against the head. TheAuri®Clip forms part of the patented Auri®Method which consists of threeproducts:

-   -   i) The Auri®Clip.    -   ii) The Auri®Strip, a special plaster.    -   iii) The Auri®Protective Spray.

According to the manufacturer, the Auri®Clip is a brace measuring 1 inch(2.5 cm) on all sides which is fixed to the ear during the night or day(FIGS. 5 a and 5 b). It consists of three parts: the part behind theear, the part in front of the ear, and a lock. The Auri®Strip is a verythin (0.2 mm thick), transparent and double-sided medical adhesivematerial that is invisible when worn and can also be used to reshape theantihelical fold (FIGS. 6 a to 6 c). The Auri®Protective Spray is usedtogether with the Auri®Clip and Auri®Strip to prevent problems with skinirritation due to prolonged usage of the Auri®Clip. The makers claimthat 3 to 6 months treatment is enough to have a permanent effect. Moreinformation on the use of the device is available fromhttp://www.aurimethod.com/index.htm.

This technique has the disadvantage that the clips cause skin irritationin some patients. Furthermore, correction of the deformities may not becomplete.

Nose deformities are also common in the human population. Deformities ofthe nose include, for example, having a broad tip, bifid tip or clefttip. Rhinoplasty (nose shaping surgery) has conventionally been used toaddress these deformities. Noses may be made smaller using reductionrhinoplasty, or enlarged using augmentation rhinoplasty. Such surgeryusually involves separating the skin of the nose from its supportingframework of bone and cartilage. In conventional rhinoplasty both thebone and the cartilage may need to be reshaped. Bone, which formsapproximately one-third of the nose, is relatively easy to reshape. Incontrast, cartilage, which forms the remaining two-thirds, is relativelydifficult to reshape. This is particularly true for the tip of the nose.

There are several disadvantages of conventional rhinoplasty. Forexample, traumatic dissection of the nose may damage nasal cartilages.There is also a risk of skin necrosis. Furthermore, asymmetry may bemade worse by surgery. Cartilage grafts are often in short supply,especially in revision procedure and in cleft lip noses. Furthermore,the operations are often lengthy and the surgeon must be highly skilled.Training of a sufficiently skilled surgeon to perform rhinoplasty istime consuming and costly. Moreover, there are disadvantages ofconventional rhinoplasty to the patient. The operation may be painfuland there is a risk of adverse reaction, or even death due to thegeneral anaesthetic. Furthermore, the results of surgery may beunpredictable and irregularities may be observed, particularly on thetip or dorsum. There is also a risk of recurrence of the deformity.

The present invention aims to address at least some of the problems anddisadvantages of the prior art.

According to a first aspect of the present invention there is provided ascaffold for reshaping an ear or a nose, the scaffold being configuredto be i) attached to the cartilaginous portion of an ear or ii) attachedto the cartilaginous portion of the nose, wherein the scaffold is formedat least in part from a shape-memory material and/or a plastic material,and is capable of transforming from a first configuration to a second,pre-programmed configuration.

Preferably, the scaffold for reshaping an ear or a nose comprises a bodyportion and at least one engaging member for engaging the cartilaginousportion of an ear or a nose, wherein the scaffold is formed at least inpart from a shape-memory material and/or a plastic material and iscapable of transforming from a first configuration to a second,pre-programmed configuration.

In a second aspect, the present invention provides a method of reshapingan ear or a nose comprising

providing a scaffold as described above,

introducing at least part of the scaffold into an ear or a nose and

altering the scaffold to cause the scaffold to transform from its firstconfiguration to its second, pre-programmed configuration.

In a third aspect, the present invention provides an applicator forinserting the scaffold as defined herein into an ear or nose, theapparatus comprising means for releasably retaining the scaffold andmeans for deploying the scaffold into the ear or nose.

By the term “scaffold” as used herein is meant any biocompatiblestructure or framework, which may be used to reshape an ear or a nose.Preferably, upon implantation into a patient the scaffold does notadversely react with a patient.

The scaffold may be suitable for reshaping the anti-helical fold of theear and/or for reshaping the conchal fossa of the ear.

The scaffold for reshaping an ear or nose may comprise a body portionand at least one engaging member for engaging in the cartilaginousportion of an ear or for engaging in the cartilaginous portion of anose, respectively.

The body portion of the scaffold for reshaping an ear or a nose may havethe shape or substantially the shape of a rectangle, a square, arhombohedra, a circle, or another regular or irregular polyhedron. Ifthe body portion shape has corners, it may be advantageous to round thecorners or edges or otherwise alter them such that there are as fewsharp corners/edges as possible. The body portion may be symmetric orasymmetric.

Preferably, the body portion of the ear scaffold will be from 0 to 35millimeters long, from 0 to 10 millimeters wide and from 0 to 2millimeters thick. More preferably, it will be from 5 to 25 millimeterslong, from 5 to 9 millimeters wide and from 0.2 to 1.8 millimetersthick. Most preferably, it will be from 10 to 20 millimeters long, from4 to 8 millimeters wide and from 0.5 to 1.5 millimeters thick.

Preferably, the body portion for the nose scaffold will be an irregularpolyhedron.

Preferably, the body portion of the nose scaffold will have a length offrom 20 to 35 millimeters, width from 0 to 15 millimeters and athickness of from 0 to 2.5 millimeters. More preferably, the bodyportion for the nose scaffold will be have a length from 25 to 30millimeters, a width of from 5 to 10 millimeters and a thickness of from0.5 to 2.0 millimeters.

Preferably, the engaging member for engaging in the cartilaginousportion of an ear is of suitable dimensions for engaging in thecartilaginous portion of an ear, without the risk of protruding throughthe skin of the ear. Similarly, the engaging member for engaging in thenose will preferably be of a suitable size for engaging in the nasalcartilage, but without the risk of protruding through the skin. It willbe understood by the skilled person that the suitable dimensions mayvary with the size of the ear or nose in which the scaffold is to beimplanted. Hence it may vary for a child and for an adult. Preferably,the engaging member has dimensions of less than, or equal to thecartilaginous portion of the ear of nose.

Preferably, the engaging members for engaging in the ear cartilage willbe from 0 to 5 millimeters long and from 0 to 1.5 millimeters indiameter. More preferably, the engaging members for engaging in the earcartilage will be from 1 to 4 millimeters long and from 0.5 to 1millimeters in diameter.

Preferably, the engaging members for engaging in the nose cartilage willbe from 0 to 5 millimeters and 0 to 1.5 millimeters. More preferably,from 1 to 4 millimeters long and from 0.5 to 1 millimeters in diameter.

The engaging members on a particular body portion may have the samelength and/or width as one other engaging members on a given bodyportion. Alternatively, at least one engaging members may have adifferent length and/or width to another engaging member on a given bodyportion. Preferably, all engaging members on a particular body portionwill all be of equal length and/or width.

The engaging members of the present invention may, for example, be inthe form of spikes, prongs, tines, or cylindrical or branchedprotrusions. Preferably, the scaffold comprises a plurality of engagingmembers extending from the body portion.

The number of engaging members per body portion may be varied dependingon the deformity being corrected. Preferably, the body will have atleast two engaging members, more preferably it will have at least four,most preferably at least six.

The engaging members may be arranged symmetrically, or asymmetrically onthe body portion.

The engaging members may all be positioned on the face of the bodyportion. Alternatively, at least one of the engaging members mayprotrude from a different face of the body portion. The engaging membersmay be positioned towards the edge of the body portion, or/and towardsthe centre of the body portion.

The scaffold for reshaping an ear or nose of the present invention maycomprise a body portion without engaging members. Such a scaffold may beheld in the desired position in the ear or nose by, for example, theoverlying skin. It may be advantageous for a scaffold without engagingmembers to be used in the present invention as this may simplifyapplication and/or removal of the scaffold to/from the ear or nose.Preferably, when the scaffold of the present invention is placed in theanterior surface of the ear, the scaffold is without engaging members.

In one embodiment of the present invention, it is advantageous for asubstantial part of the body of the scaffold to have a substantiallysmooth surface. This allows the scaffold to be easily deployed in orremoved from the nose or ear. In this embodiment it is preferable forthe body not to comprise engaging members. When no engaging members arepresent on the scaffold it has been found to be advantageous for thebody of the scaffold to have a width of less than 10 millimeters,preferably less than 5 millimeters and most preferably less than 3millimeters. The length of the body is preferably greater than 10millimeters, more preferably greater than 12 millimeters and mostpreferably less than 15 millimeters. Without wishing to be bound by anytheory the present inventors have discovered that when the length of thescaffold is less than 10 millimeters and there are no engaging members,the frictional forces between the cartilage and the scaffold are notsufficient in order to allow the cartilage to grip the cartilagesatisfactorily.

In a further embodiment of the present invention the body of thescaffold is designed so that the frictional contact between the scaffoldand the cartilage when in place in the nose or ear is increased comparedto a scaffold which has a substantially smooth surface. This may beachieved, for example, by designing the scaffold such that at least aportion of the surface of the scaffold has a rough surface. In order toease application of such an embodiment, the scaffold may be designed sothat only a portion of the scaffold has a roughened surface, and theremaining portion is smooth. Preferably the central portion of thescaffold has a roughened surface and the edge portions are substantiallysmooth to allow easy deployment of the scaffold into the nose or ear(see for example FIG. 18 b).

Preferably the body portion of the scaffold is tapered to narrow at oneend. More preferably the body portion will taper to a narrower head end,and have a wider tail end. The head end being designed to be insertedinto the patient first. The tapering of the scaffold preferablydecreases the lateral damage made to the skin when the scaffold isinserted or removed.

The edges of the scaffold may be straight, curved, wavy, serrated or acombination. It may be advantageous for the edges not to be straight sothat the edge engages with the skin and provides more anchorage of thescaffold to the cartilage.

It will be understood that the scaffold for reshaping an ear or a nosemay be designed to stay in the body of the patient for a substantiallength of time, for example, at least two years, or more preferably atleast five years. Alternatively, the scaffold may be designed to betaken out of the patient after, for example, less than two years, orless than one year, or less than six months.

The scaffold of the present invention is formed at least in part from ashape-memory material and/or a plastic material and is capable oftransforming from a first configuration to a second, pre-programmedconfiguration.

The first and/or second configuration of the scaffold may be in aconstrained or a non-constrained state. Preferably, the firstconfiguration is in constrained state and the second configuration is ina non-constrained or vice versa.

Preferably, either the first or the second pre-programmed configurationis substantially curved and the other configuration is substantiallystraight.

Preferably, the first and/or second configuration of the scaffold ispre-programmed to conform to the shape of the ear or the nose. Forexample, it may be pre-programmed to be substantially the shape of, orat least part of the shape of, an antihelical fold, a conchal fossa, ora nasal cavity.

Preferably, the body portion and/or at least one engaging member may beformed at least in part from the shape-memory material and is capable oftransforming from a first configuration to a second, pre-programmedconfiguration.

The term “shape-memory material” is well known in the art. As usedherein the term may be defined as a material which is capable oftransforming from a first configuration to a second, pre-programmedconfiguration. This may be initiated by a change in temperature.

The shape memory material of the present invention may be a metal alloyor a shape memory polymer.

Preferably, the alloy used is a shape memory alloy of nickel andtitanium. Most preferably, the alloy comprises approximately 50% nickeland 50% titanium by weight of the total composition.

Preferably, the nickel titanium alloy used in the present invention isof the type disclosed in U.S. Pat. No. 3,174,851, which is known as“Nitinol”. Details of such materials may be found is NASA Publication SP5110 entitle “55-NITINOL”—The Alloy with a Memory, Its physicalMetallurgy, Properties, and Applications, C. M. Jackson et al, 1972.Many other materials having similar characteristics are well known.

The property of nitinol which may be exploited in the present inventionis the ability to pre-program a particular shape into the metal alloyand to activate the “memory” of this shape by heating/cooling it tospecific temperatures. Using this property, it is possible to controlthe point at which the nitinol changes shape to within from 1 to 10° C.,preferably within from 1 to 5° C. and most preferably within from 1-2°C. Preferably, the temperature range over which the scaffold changesfrom the first to the second and/or the second to the firstconfiguration is narrow.

The scaffold of the present invention may comprise a plastic material,which may be thermoplastic. This material may be biodegradable.Furthermore, it may have shape-memory properties.

Preferably, the scaffold comprises a plastic material which is abiodegradable and/or bioabsorbable elastomer with shape memoryproperties. Examples of such materials may be found in Medical DeviceTechnology, April 2005. Examples of such materials include, but are notlimited to, poly(ε-caprolactone), or those based on crystallisablemacrodiols, which may be synthesised from poly(p-dioxanone)diols andpoly(ε-caprolactone)diol.

The scaffold of the present invention may comprise bioabsorbable or abiodegradable material, which may be a polymer or a copolymer. Examplesof bioabsorbable materials which may be used in the present inventioninclude, but are not limited to, synthetic materials such as polyaceticacid, polyglycolic acid, polydioxanone, polytrimethylene carbonate,poly(ethylene carbonate), poly(iminocarbonates), polycaprolactone,polyhydroxybutyrate, polyalkylene oxalates, polyalkylene succinates,poly(maleic acid), poly(1,3-propylene malonate), poly(ethyleneterephthalate), poly(amino acids) and VICRYL™ (a bioabsorbable copolymerof glycolide and lactide). Preferably, the bioabsorbable material is apolydioxanone homopolymer. It will be understood that the selection of asuitable absorbable material will depend on such factors as the desiredin vivo strength properties and absorption rate required for thescaffold.

One aspect of the present invention provides a method of reshaping anear or a nose comprising

providing a scaffold as described herein,

introducing at least part of the scaffold into an ear or a nose and

altering the scaffold to cause the scaffold to transform from its firstconfiguration to its second, pre-programmed configuration.

Preferably, the present invention provides a method of reshaping an earor a nose comprising

providing a scaffold, wherein said scaffold comprises at least oneengaging member as described herein, introducing at least one engagingmember of the scaffold into a cartilaginous portion of an ear or a nose,and altering the scaffold to cause the scaffold to transform from itsfirst configuration to its second, pre-programmed configuration.

Preferably, the temperature of at least some of the scaffold is alteredto cause the scaffold to transform from its first configuration to itssecond, pre-programmed configuration. Alternatively, or additionally,force may be applied or released to the scaffold to transform thescaffold from one configuration to another.

The temperature of the scaffold may be increased or decreased to causethe scaffold to transform from its first configuration to its second,pre-programmed configuration.

It will be understood that the temperature ranges desired for transitionof the scaffold from one configuration to another may be determined bythe tolerance of animal/human tissue to heating and cooling, and totemperature fluctuations experienced in the nose and ear during everydaylife. Preferably, the temperature of the scaffold of the presentinvention will remain from −20° C. to 45° C., more preferably from 0 to42° C., most preferably, from 15 to 40° C. It is known that exposure ofanimal/human tissue for prolonged periods (greater than 1 minute) totemperatures above 40° C. may result in permanent damage to the tissuesand prolonged exposure (hours) of the whole organism to temperaturesabove this level is not usually compatible with life. Similarly,exposure of animal/human tissue to prolonged periods to sub-zerotemperatures is likely to damage the tissue and may lead in some casesto frost-bite. Thus prolonged exposure of the tissues to extremetemperatures is preferably avoided or minimised.

In one embodiment, wherein the scaffold comprises a body portion and atleast one engaging member, the present invention provides a methodcomprising

introducing at least one engaging member of the scaffold into thecartilaginous portion of an ear or a nose when the scaffold is at anelevated temperature, and wherein the scaffold transforms from its firstconfiguration to its second, pre-programmed configuration as thescaffold cools below a predetermined temperature.

Preferably, the scaffold of the present invention is in a firstconfiguration at room temperature (for example from 20 to 25° C.) and atanimal/human body temperature (for example from 35 to 40° C.). Thisfirst configuration may be curved. Upon heating the scaffold aboveanimal or human body temperature, to for example about 41 to 42° C., thescaffold transforms into a second pre-programmed configuration. Thesecond configuration may be substantially straight. The scaffold maythen be inserted into the animal or human whilst the scaffold is in itssecond configuration. Inserting the heated scaffold may only take a fewseconds, thus tissue damage is limited. Once the scaffold has beeninserted into the cartilage of the ear or nose, it may be rapidlycooled, for example, by dousing with water. Upon cooling, the scaffoldis pre-programmed to transform into its first configuration and tosubsequently remain in that configuration at a temperature ofapproximately 37° C. This may be advantageous since the mammalian bodiesof particular interest to this invention usually have a temperature ofapproximately 35 to 40° C.

In another embodiment, the method of the present invention may furthercomprise manually altering the configuration of the body portion and/orat least one engaging member of the scaffold once the scaffold ispositioned in the ear or in the nose.

In addition to the methods described above, the method of the presentinvention may further comprise altering the temperature of the scaffoldto cause the scaffold to transform from its second, pre-programmedconfiguration to its initial configuration to allow the scaffold to beremoved from the ear or from the nose.

Preferably, the shape memory material of the present invention is heatedby passing an electric current through the shape memory material or byadjacent heating elements. This may permit precise control of the shapeof the scaffold implant during the insertion process/reshaping process.

The method of the present invention is minimally invasive compared withstandard otoplasty surgery. Thus the present invention provides a methodof reshaping an ear or a nose which carries a reduced risk ofcomplications compared to the more extensive dissection required withstandard techniques. Thus, by using the method of the present inventionthere should be fewer problems with scarring, bleeding, skin necrosisand sharp folds in the cartilage.

It will be understood that the scaffold of the present invention can beapplied quickly. It may take only 10-15 minutes to correct both earscompared with conventional otoplasty which takes up to 45 minutes foreach ear.

Since the scaffold is buried under the skin and embedded in thecartilage. It does not suffer the problems encountered with poorcompliance by the patient using non-surgical techniques such asEarbuddies™ or Auri®Clips.

One advantage of using the scaffold of the present invention is that theoutline form of the reshaped nose or ear is highly predictable andreproducible compared to standard techniques. For example, the curvatureof the antihelical fold is highly predictable and reproducible comparedwith standard techniques. Thus, there is less risk of problems ofasymmetry compared with conventional otoplasty surgery.

It will be understood that application of the present invention willresult in the immediate correction of the ear or nose deformity, unlikesome methods described in the prior art, for example Earbuddies™ orAuriclip, which must be used for extended periods of time to achieve thecorrection desired by the patient.

Each aspect as defined above may be combined with any other aspect oraspects unless clearly indicated to the contrary. In particular anyfeature indicated as being preferred or advantageous may be combinedwith any other feature or features indicated as being preferred oradvantageous.

The present invention will now be described further, by way of example,with reference to the accompanying drawings, in which:

FIGS. 1 a and 1 b show schematic illustrations of an ear;

FIGS. 2 a and 2 b show photographs of a prominent ear due to a deformedantihelical fold before and after treatment;

FIGS. 3 a and 3 b show photographs of a prominent ear due to a deepconchal fossa;

FIGS. 4 a to 4 c show photographs of a young child's ear before, duringand after treatment with Earbuddies®;

FIGS. 5 a and 5 b show photographs of an Auriclip® in use and anillustration of an Auriclip®;

FIGS. 6 a to 6 c show an illustration of a prominent ear without andwith an Auri®strip (FIGS. 6 a and 6 b respectively), and photograph ofan Auri®strip (FIG. 6 c);

FIGS. 7 a to 7 c show schematic illustrations of one embodiment of thepresent invention being positioned in an ear;

FIGS. 8 a and 8 b show schematic illustrations of an ear scaffold of thepresent invention;

FIGS. 9 a to 9 e show schematic illustrations of an ear scaffold of thepresent invention being inserted into an ear using an applicator;

FIGS. 10 a and 10 b show schematic illustrations of an ear before andafter insertion of a scaffold of the present invention;

FIGS. 11 a to 11 c show illustrations of an applicator which may be usedto insert the present invention into the patient;

FIGS. 12 a to 12 e show the use of the present invention to correct deepconchal fossa;

FIGS. 13 a to 13 d show schematic illustrations of a nose without ascaffold (FIG. 13 a), with a scaffold (FIGS. 13 b and 13 c); and thescaffold (FIG. 13 d);

FIG. 14 shows a preferred embodiment of an applicator for the scaffoldof the present invention;

FIG. 15 shows an enlarged illustration of a slider which may form partof the applicator for a scaffold;

FIG. 16 shows the slider of FIG. 15 in place on an applicator, such theone shown in FIG. 14;

FIG. 17 shows an applicator with a locator device; and

FIGS. 18 a and 18 b show cross-sections of portion (18) of theapplicator of the present invention.

FIG. 1 a shows a schematic illustration of the front view of a humanear, showing the antihelical fold (1), and the conchal fossa (2). In anormal ear the cartilage (3) of the ear normally protrudes approximately15 to 17 mm from the skin (4) This distance is illustrated in FIG. 1 b,which shows a cross-sectional view of an ear taken along the line markedX on FIG. 1 a.

The photograph FIG. 2 a shows a prominent ear due to the absence of, ora poorly formed, antihelical fold. This may be corrected by creating anantihelical fold as part of otoplasty (as shown by the dotted line inFIG. 2 b).

FIG. 3 a shows a photograph of a prominent ear due to the presence of adeep conchal fossa. Normally, a wedge of cartilage must be removed fromthe ear to reduce the ear's prominence (as shown in the highlightedsection of FIG. 3 b).

FIGS. 4 a to 4 c show photographs of a young child's ear before, duringand after treatment with Earbuddies. FIG. 4 a shows a child's ear whichis prominent at birth. FIG. 4 b shows an “Earbuddy”® in place in thechild's ear. FIG. 4 c shows the child's ear after treatment.

FIG. 5 a shows a photograph of an Auriclip® in use. FIG. 5 b shows aphotograph of an Auriclip® in more detail. The Auriclip® has a memberover which the ear cartilage is folded. The Auriclip® folds the earcartilage by pushing the cartilage from behind.

FIG. 6 a shows an illustration of an ear before treatment. FIG. 6 bshows an illustration of an ear with a Auristrip® in place behind theear creating an antihelical fold. FIG. 6 c shows Auristrips® cut to sizeto fit behind an ear.

FIG. 7 a shows an illustration of a prominent ear due to the absence ofan antihelical fold. FIG. 7 b shows three small incisions that have beenmade on the posterior of the skin of the ear. A small subcutaneoustunnel is made at each incision to allow the ear scaffold to beinserted. FIG. 7 c illustrates the scaffolds being inserted and fixedinto an ear.

A schematic illustration of one embodiment of the scaffold of thepresent invention is shown in FIG. 8 a. The body of the scaffold (6) maycomprise nitinol (or a similar material). The body may comprisebioerodible material. Engaging members (5) may be attached to the bodyof the scaffold. The engaging members may be tines, or prongs to bedriven into the cartilage. The scaffold may be bent into shape or may bepre-programmed to a specific degree or curvature (FIG. 8 b).

FIGS. 9 a to 9 e illustrate one self-explanatory method of inserting thescaffold into the cartilage of an ear. The scaffold may be mounted onthe tip of the applicator (FIG. 9 a). The scaffold may then be deployedinto the cartilage (3).

FIG. 10 a shows an illustration of a cross section of an ear beforeinsertion of the scaffold. FIG. 10 b shows the scaffold in place in theear. The scaffold may be designed such that it can be bent to reshapethe antihelical fold by a desired amount, or the ear staple may bepre-programmed to bend with a certain degree of curvature which may beselected before insertion.

FIGS. 11 a to 11 c illustrate an applicator which may be used to insertthe scaffold of the present invention into an ear or nose. In thisembodiment, the applicator (8) has a battery pack in its handle, whichmay be switched on to heat the scaffold via switch (7). A trigger may beused to operate the anvil which drives the ear staple into thecartilage. FIG. 11 b shows an enlarged illustration of the anvil (10).The ear staple is held towards the end of the applicator (9).Advantageously the ear staple may be held straight during application tothe cartilage. The applicator is then slide off allowing the ear stapleto return to its curved shape upon cooling. FIG. 11 c shows heatingelements (11) at the tip of the applicator (8).

FIGS. 12 a to 12 d illustrate cross sections of an ear staple (13) beinginserted into an ear to correct prominence due to deep conchal fossa.FIG. 12 e shows a side view of an ear showing the scaffold in place (15)and the incision made in the conchal fossa to place the scaffold (14).

FIGS. 13 a to 13 d show a scaffold (FIG. 13 d) of the present inventionbeing inserted into a human nose. The skin envelope of the nose isreleased (FIG. 13 a). The scaffold is then inserted into the nosecartilage (FIG. 13 b). The scaffold may be secured in place by drivingthe engaging members into the cartilage. The scaffold may then betransformed into the predetermined shape (FIG. 13 c). In FIG. 13 c, thescaffold is secured to the alar cartilages by driving the tines(engaging members) into the cartilage. Once secure, the nasal cartilagespreferably conform to the shape of the scaffold reshaping the nose.

FIG. 14 shows a preferred embodiment of an applicator for the scaffoldof the present invention. The applicator may comprise a handle (19), aportion (18) on which the scaffold (not shown) is held prior toinsertion by a retaining means (17), and a protruding section (16) whichhelps to position the scaffold on the applicator upon insertion to thenose or ear. The scaffold is positioned on portion (18) of theapplicator prior to insertion. The portion (18) preferably holds thescaffold in the first configuration. The applicator is then insertedinto a skin incision made in the ear or nose. Preferably only theportion (18) is inserted into the incision. To facilitate insertion ofthe applicator into the incision the applicator may be tapered towardsthe distal end, preferably along the portion (18) as shown in FIG. 14.The retaining means (17) may be a groove as shown in FIG. 14 into whichthe scaffold is designed to rest. The retaining means may be a channelfor releasably retaining the scaffold. The handle (19) may be designedsuch that a finger may be inserted into it. Preferably the handle isdesigned for insertion of the middle finger. The index finger may thenbe used to steady the applicator.

Preferably the applicator has stop means for stopping further deploymentof portion (18) into the nose or ear. For example, the stop means may bea protruding section (16) as shown in FIG. 16.

Preferably the applicator retains the scaffold in a first configuration.

After the applicator has been inserted under the skin the scaffold maybe deployed into position by pushing the scaffold from portion (18) ofthe applicator and removing the applicator from the nose or ear. Thescaffold may be deployed from the applicator by means of a slider (20)(FIG. 15) which is positioned on the applicator as shown in FIG. 16. Thescaffold bends into the pre-programmed shape as it is deployed from theapplicator.

The applicator may further comprise a locator means (21) attached to theslider (20). The locator means is designed to help the operator tolocate the position of the centre of the scaffold when it has beeninserted under the skin. This will allow the operator to ensure that thescaffold is located directly over the middle of the antihelical fold.One example of a locator means is shown in FIG. 17.

FIG. 18 a shows the cross section of portion 18 of the scaffoldapplicator. The scaffold (25) is retained on the applicator prior toinsertion in a groove (22) or channel in portion (18) of the applicator.In this example the scaffold has a substantially smooth surface so thatinsertion of the scaffold from the applicator is facilitated.

FIG. 18 b shows possible alternative to the cross section of portion(18) of the applicator. In this embodiment the scaffold is designed tohave a roughed surface (23) over at least some of its body. In order toease application of such a scaffold (26), portion (18) may have afurther groove (24) or channel to make space for the roughened surface(23).

Embodiment 1

In a first example of the present invention, a scaffold is used toreshape the antihelical fold of the ear with the aim of correcting aprominent ear (see FIGS. 1 a and 1 b).

In this example, to change the shape of the antihelical fold, a thinstrip of nitinol metal alloy (or material with similar properties) isinserted into the subcutaneous space of the skin on the posterior aspectof the ear through a small incision or series of incisions (FIGS. 7 a to7 c).

The scaffold of the present invention may also be effective when placedinto the subcutaneous space on the anterior aspect of the ear. However,it may be more advantageous for placement at the posterior position,because this will reduce the likelihood that the engaging member (andany incision to insert it) may become visible overtime.

In this example the scaffold is shaped with several thin “spikes”,“prongs” or “tines” along its length (or just at each end) on one sideof the strip (FIGS. 8 a and 8 b). The purpose of these spikes or tinesis to allow the scaffold to be fixed securely into the cartilage of theear.

To fix the scaffold to the cartilage, a specially designed applicatormay be used to hold the scaffold in the correct position in relation tothe antihelical fold of the ear (FIGS. 1 a, 1 b and FIGS. 9 a to 9 e).Once it is in the correct position (FIG. 9 a), the applicator isdeployed to drive the tines into the cartilage (FIG. 9 b). This methodmay be sufficient to hold the scaffold securely (FIG. 9 c).Alternatively, it may be necessary to cause the tines to curve over attheir tips (FIG. 9 d) to bind the scaffold more closely to thecartilage.

Once the scaffold is secured to the cartilage it is either bent into thedesired shape by the user (causing the antihelical fold to be formed) orit is allowed to bend into a pre-programmed shape (FIG. 10 b). Thelatter method allows different degrees of curvature to be pre-programmedinto the invention before insertion.

The specific degree of curvature of the antihelical fold required tocorrect the prominence may be measured, prior to design of the scaffold.The scaffold may then be designed to specific measurements. The resultsof this method of correction would be highly predictable andreproducible compared with conventional techniques.

A possible applicator used to insert the invention is shown in (FIGS. 11a to 11 c). The applicator may be electrically driven. This allows theshape pre-programmed into the nitinol metal alloy to be activated oncommand. The pre-programmed shapes could include, for example, a shapewhere the tines are either straight or curved. The ability to controlthe shape of the tines would facilitate removal of the invention fromthe ear. This might be necessary to allow the position of the inventionto be adjusted infinitely to produce the desired effect and would removeany concern about the learning curve required to produce a particularoutcome.

It is anticipated that a maximum of three and a minimum of one of thescaffolds may be required to produce the desired curvature of theantihelical fold (FIGS. 7 a to 7 c). Once inserted, the inventions wouldbe left in place permanently but could be removed at a later date ifproblems were to develop.

Embodiment 2

In a second embodiment of the present invention, a scaffold is used tocorrect deep conchal fossa (see FIGS. 3 a, 3 b and FIGS. 12 a to 12 e).

An incision is made in the conchal fossa to facilitate insertion of thestaple (FIGS. 12 b and 12 e). A separate incision is made behind the earto allow the soft tissues to be repositioned (FIG. 12 b). The ear ispushed back alongside the head by the desired amount (FIG. 12 b). Astaple is inserted through the anterior incision which holds the ear inthe desired position (FIGS. 12 c and 12 e). The engaging members, forexample, the tines or spikes will then be made to curve over holding thestaple in the correct position (FIG. 12 d) as with the invention forreshaping the antihelical fold.

Embodiment 3

In the third embodiment of the present invention a scaffold is used tocorrect a deformed nose (see FIGS. 13 a to d).

The skin envelope is released from the nose to allow reshaping of thedeformed nasal cartilage. The nose scaffold used to correct thedeformity, in this example, comprises two bent body portions. Eachportion comprises a substantially straight part, and a curved part. Thecurved part comprises engaging members which may be used to engage inthe cartilage of the nose.

The scaffold is inserted into the cartilage of the nasal cavity. Theskin envelope is then draped over the new cartilage scaffold.

The scaffold is then secured to the alar cartilage by driving theengaging members into the cartilage. The engaging members are thanheated (or they may be cooled in other embodiments of the presentinvention) to cause the engaging members to curve into the alarcartilage. In other embodiments of the present invention, the engagingmembers need to curve upon transition to a second pre-programmedconfiguration.

Once the scaffold is in place. The nasal cartilage may conform to thenew scaffold shape, giving the nose a new shape.

1. A scaffold for reshaping an ear or a nose, the scaffold configured tobe (i) attached to the cartilaginous portion of an ear or (ii) attachedto the cartilaginous portion of a nose, wherein the scaffold is formedat least in part from a shape memory material and is capable oftransforming from a first configuration to a second pre-programmedconfiguration, wherein the scaffold comprises a body portion and aplurality of engaging members in the form of prongs extending from thebody portion for engaging the cartilaginous ear or nose portion.
 2. Ascaffold as claimed in claim 1, wherein the scaffold is transformablefrom said first configuration to said second configuration at apredetermined temperature or over a predetermined temperature range. 3.A scaffold as claimed in claim 1 wherein the first configuration is in aconstrained state and the second configuration is in a non-constrainedstate.
 4. A scaffold as claimed in claim 1 wherein the firstconfiguration is in a non-constrained state and the second configurationis in a constrained state.
 5. A scaffold as claimed in claim 1 whereinthe first configuration is pre-programmed to conform to the shape of anear or nose.
 6. A scaffold as claimed in claim 1 wherein the secondconfiguration is pre-programmed to conform to the shape of an ear ornose.
 7. A scaffold as claimed in claim 1 wherein the first or thesecond configuration is substantially curved and the other configurationis substantially straight.
 8. A scaffold as claimed in claim 1, whereinthe body portion is formed at least in part from the shape-memorymaterial and is capable of transforming from a first configuration to asecond, pre-programmed configuration.
 9. A scaffold as claimed in claim1, wherein the at least one engaging member is formed at least in partfrom the shape-memory material and is capable of transforming from afirst configuration to a second, pre-programmed configuration.
 10. Ascaffold as claimed in claim 1, which is suitable reshaping theanti-helical fold of the ear.
 11. A scaffold as claimed in claim 1,which is suitable for reshaping the conchal fossa of the ear.
 12. Ascaffold as claimed in claim 1, wherein the shape-memory material is analloy of nickel and titanium.
 13. A method of reshaping an ear or a nosecomprising providing a scaffold configured to be (i) attached to thecartilaginous portion of an ear or (ii) attached to the cartilaginousportion of a nose, wherein the scaffold is formed at least in part froma shape memory material and is capable of transforming from a firstconfiguration to a second pre-programmed configuration, wherein thescaffold comprises a body portion and a plurality of engaging members inthe form of prongs extending from the body portion for engaging thecartilaginous ear or nose portion, introducing at least part of thescaffold into an ear or a nose and altering the scaffold to cause thescaffold to transform from its first configuration to its second,pre-programmed configuration.
 14. A method of reshaping an ear or a noseas claimed in claim 13, wherein at least one of said engaging members isintroduced into a cartilaginous portion of an ear or a nose.
 15. Amethod as claimed in claim 13, wherein the temperature of the scaffoldis altered to cause the scaffold to transform from its firstconfiguration to its second, pre-programmed configuration.
 16. A methodas claimed in claim 15, wherein the at least one engaging member of thescaffold is introduced into the cartilaginous portion of an ear or anose when the scaffold is at an elevated temperature, and wherein thescaffold transforms from its first configuration to its second,pre-programmed configuration as the scaffold cools below a predeterminedtemperature.
 17. A method as claimed in claim 13 which further comprisesmanually altering the configuration of the body portion and/or at leastone engaging member of the scaffold once the scaffold is positioned inthe ear.
 18. A method as claimed in claim 13, which further comprisesaltering the temperature of the scaffold to cause the scaffold totransform from its second, pre-programmed configuration to its initialconfiguration to allow the scaffold to be removed from the ear.